Efficacy of a Treatment Based on Olive Leaf Extracts in the Control of Cardiovascular Risk Factors:Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- rate of blood pressure reduction
研究概览
简要总结
This study will be carried out in 2 emergency departments (at the exit of the emergency room) and 2 external consultations (endocrinology of the CHU FB Monastir and diabetology consultation, Jemmal hospital).
Patients over 18 years of age with:
Arterial hypertension (hypertension).
详细描述
This study will be carried out in 2 emergency departments (at the exit of the emergency room, patients included in the GR2 study) and 2 external consultations (endocrinology of the CHU FB Monastir and diabetology consultation, Jemmal hospital).
All the population will benifit of a biological assessment which include:
Complete lipid profile, blood sugar, creatinine
one population will be randomized:
The population of patients with hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients over 18 years of age with:
- •Arterial hypertension (hypertension)
排除标准
- •. Exclusion criteria: None.
研究组 & 干预措施
atherolive-drug
The patient will be assigned to one of two treatments (atherolive ) using a computer-generated randomization list (1: 1 allocation). The investigator who has the randomization code is not involved in other study procedures and does not interact with participants. The study drug (atherolive) will be prescribed at a dose of 400 mg, once a day for 3 months.
干预措施: atherolive-drug (Drug)
atherolive-placebo
The patient will be assigned to one of two treatments using a computer-generated randomization list (1: 1 allocation). The investigator who has the randomization code is not involved in other study procedures and does not interact with participants. The study drug (atherolive-placebo) will be prescribed at a dose of 400 mg, once a day for 3 months.
干预措施: Placebo Atherolive (Drug)
结局指标
主要结局
rate of blood pressure reduction
时间窗: 90 days
blood pressure reduction on 24 hours holter
次要结局
- rate of lipid balance variation The secondary endpoint(90 days)
研究者
Pr. Semir Nouira
clinical proffesor
University of Monastir